Metabolic Syndrome (MetS)NCT07183137
Metabolic Surgery for Metabolic Syndrome
An observational study of Metabolic Syndrome (MetS) and Hypertension (HTN), run by The Third Xiangya Hospital of Central South University at 3 sites in China.
Trial summary
This study is designed to understand how bariatric surgery affects patients with metabolic syndrome over both the short and long term. We will track changes in blood pressure and other health indicators for up to 10 years after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome (MetS), Hypertension (HTN), Obesity
- How many people
- 1,581 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2010to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 65 years who were scheduled to undergo bariatric surgery, including laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG), at three participating medical centers in China. Patients were selected based on guideline-based indications for bariatric surgery at the time of recruitment. For the primary analysis, only patients with hypertension were included, defined as meeting at least one of the following criteria: (1) systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; (2) self-reported or physician-diagnosed hypertension; or (3) current use of antihypertensive medications. Patients with coexisting cardiac insufficiency, renal dysfunction, contraindications to surgery or anesthesia, or who declined participation were excluded. Additional exclusions during the data analysis phase included patients who experienced severe postoperative adverse events within 7 days, had fewer tha
Who may be able to join
- (1) aged 18-65 years; (2) scheduled to undergo bariatric surgery, including laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG); and (3) met the guideline-based indications for surgery at the time of operation.
Who cannot join
- (1) coexisting cardiac insufficiency or renal dysfunction; (2) contraindications to bariatric surgery or anesthesia; and (3) refusal to provide informed consent.
Trial locations and contacts
3 sites in 1 country.
China3 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
The third xiangya hospital of Central South University
Changsha, Hunan, 410013
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510168
About this study
Official title: A Prospective Observational Study on Metabolic Surgery for the Treatment of Metabolic Syndrome
This study is designed to understand how bariatric surgery affects patients with metabolic syndrome over both the short and long term. We will track changes in blood pressure and other health indicators for up to 10 years after surgery. The goal is to see whether surgery can provide lasting benefits for controlling blood pressure and improving overall health in patients with metabolic syndrome.
Read the detailed description
Metabolic syndrome (MetS) is a combination of obesity, high blood pressure, abnormal blood sugar, and lipid disorders. It greatly increases the risk of heart disease, stroke, and type 2 diabetes. In Asian populations, MetS often appears at lower body mass index (BMI) levels than in Western countries, making it a growing public health concern even among individuals without severe obesity.
Bariatric surgery has been proven to help patients lose weight and improve blood sugar, blood pressure, and cholesterol levels. However, most studies have been done in patients with severe obesity. There is limited real-world evidence on how surgery affects patients with MetS at lower BMI levels, especially over the long term. In addition, the short-term biological changes that occur immediately after surgery are not fully understood.
This study is a multicenter prospective cohort including patients who had bariatric surgery in three hospitals in China. Patients are being followed for up to 10 years after surgery.
- Early phase: From postoperative day 1 to 7, changes in blood pressure, glucose, and electrolytes are monitored to capture immediate metabolic effects.
- Long-term phase: Follow-up at 3 months, 6 months, 1 year, 5 years, and 10 years is used to assess sustained improvements in weight, blood pressure, glucose, and lipid profiles.
The primary outcome is improvement or resolution of MetS, defined by standardized criteria including BMI, blood pressure, fasting glucose, and lipid levels. Secondary outcomes include changes in individual risk factors, reduction in medication use, and the proportion of patients free of MetS over time.
By providing both short-term and long-term data, this study will clarify how bariatric surgery affects the full course of MetS. The results will help identify patients who may benefit most, guide treatment recommendations, and support better prevention of cardiovascular and metabolic diseases in Asian populations.
- Conditions
- Metabolic Syndrome (MetS), Hypertension (HTN), Obesity, T2, T2DM, Bariatric Surgery
- Keywords
- bariatric surgery, blood pressure, hypertension, T2DM, obesity
- Medical subject headings
- Metabolic Syndrome, Hypertension, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Body Mass Index
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Systolic blood pressure
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Diastolic blood pressure
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Status of hypertension
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Fasting blood glucose
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Total cholesterol
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Triglycerides
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Secondary outcomes (5)
Glycated hemoglobin
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Low-density lipoprotein (LDL)
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
High-density lipoprotein (HDL)
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
excess weight loss (EWL%)
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Fasting insulin
Measured: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Sep 2010
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome (MetS)Studies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,581 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183137
- Sponsor's protocol ID
- 2010-S008
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhong X, Cao Y, Sun X, Li P, Li W, Yuan H, Zhu S, Wu L, Meng H, Lu Y, Zhu L. Short- and Long-Term Control of Hypertension After Bariatric Surgery: A 10-Year Prospective Study. MedComm (2020). 2026 Oct 29;7(11):e71097. doi: 10.1002/mco2.71097. eCollection 2026 Nov.
PubMed 42959411
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on Metabolic Surgery for the Treatment of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07183137
- Acronym / sponsor ID
- 2010-S008
- Conditions
- Metabolic Syndrome (MetS), Hypertension (HTN), Obesity, T2, T2DM, Bariatric Surgery
- Keywords
- bariatric surgery, blood pressure, hypertension, T2DM, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,581 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to understand how bariatric surgery affects patients with metabolic syndrome over both the short and long term. We will track changes in blood pressure and other health indicators for up to 10 years after surgery. The goal is to see whether surgery can provide lasting benefits for controlling blood pressure and improving overall health in patients with metabolic syndrome.
Detailed description
Metabolic syndrome (MetS) is a combination of obesity, high blood pressure, abnormal blood sugar, and lipid disorders. It greatly increases the risk of heart disease, stroke, and type 2 diabetes. In Asian populations, MetS often appears at lower body mass index (BMI) levels than in Western countries, making it a growing public health concern even among individuals without severe obesity.
Bariatric surgery has been proven to help patients lose weight and improve blood sugar, blood pressure, and cholesterol levels. However, most studies have been done in patients with severe obesity. There is limited real-world evidence on how surgery affects patients with MetS at lower BMI levels, especially over the long term. In addition, the short-term biological changes that occur immediately after surgery are not fully understood.
This study is a multicenter prospective cohort including patients who had bariatric surgery in three hospitals in China. Patients are being followed for up to 10 years after surgery.
- Early phase: From postoperative day 1 to 7, changes in blood pressure, glucose, and electrolytes are monitored to capture immediate metabolic effects.
- Long-term phase: Follow-up at 3 months, 6 months, 1 year, 5 years, and 10 years is used to assess sustained improvements in weight, blood pressure, glucose, and lipid profiles.
The primary outcome is improvement or resolution of MetS, defined by standardized criteria including BMI, blood pressure, fasting glucose, and lipid levels. Secondary outcomes include changes in individual risk factors, reduction in medication use, and the proportion of patients free of MetS over time.
By providing both short-term and long-term data, this study will clarify how bariatric surgery affects the full course of MetS. The results will help identify patients who may benefit most, guide treatment recommendations, and support better prevention of cardiovascular and metabolic diseases in Asian populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 65 years who were scheduled to undergo bariatric surgery, including laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG), at three participating medical centers in China. Patients were selected based on guideline-based indications for bariatric surgery at the time of recruitment. For the primary analysis, only patients with hypertension were included, defined as meeting at least one of the following criteria: (1) systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; (2) self-reported or physician-diagnosed hypertension; or (3) current use of antihypertensive medications. Patients with coexisting cardiac insufficiency, renal dysfunction, contraindications to surgery or anesthesia, or who declined participation were excluded. Additional exclusions during the data analysis phase included patients who experienced severe postoperative adverse events within 7 days, had fewer tha
Key inclusion criteria (1 listed)
- (1) aged 18-65 years; (2) scheduled to undergo bariatric surgery, including laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG); and (3) met the guideline-based indications for surgery at the time of operation.
Key exclusion criteria (1 listed)
- (1) coexisting cardiac insufficiency or renal dysfunction; (2) contraindications to bariatric surgery or anesthesia; and (3) refusal to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Body Mass Index
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Systolic blood pressure
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Diastolic blood pressure
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Status of hypertension
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Fasting blood glucose
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Total cholesterol
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Triglycerides
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
5 secondary outcomes
Glycated hemoglobin
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Low-density lipoprotein (LDL)
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
High-density lipoprotein (HDL)
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
excess weight loss (EWL%)
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Fasting insulin
Time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 42959411Zhong X, Cao Y, Sun X, Li P, Li W, Yuan H, Zhu S, Wu L, Meng H, Lu Y, Zhu L. Short- and Long-Term Control of Hypertension After Bariatric Surgery: A 10-Year Prospective Study. MedComm (2020). 2026 Oct 29;7(11):e71097. doi: 10.1002/mco2.71097. eCollection 2026 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome (MetS) and Hypertension (HTN), run by The Third Xiangya Hospital of Central South University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.